Spacerless artificial disc replacements

ABSTRACT

Spacerless artificial disc replacements (ADR) are disclosed. One preferred embodiment includes two saddle-shaped components to facilitate more normal spinal flexion, extension, and lateral bending while limit axial rotation, thereby protecting the facet joints and the annulus fibrosus (AF). Either or both of the superior and inferior components are made of a hard material such as chrome cobalt, titanium, or a ceramic including alumina, zirconia, or calcium phosphate. The articulating surfaces of the ADR are also preferably highly polished to reduce friction between the components. Metals, alloys or other materials with shape-memory characteristics may also prove beneficial.

REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No. 12/789,925 (“the '925 Application”), filed May 28, 2010 and now U.S. Pat. No. 8,277,507 B2, which is a is a continuation of U.S. application Ser. No. 11/194,786 (“the '786 Application”), filed Aug. 1, 2005 and now abandoned, which is a continuation of U.S. application Ser. No. 10/413,028 (“the '028 Application”), filed Apr. 14, 2003 and now abandoned, each of said applications also claiming the benefit of the filing date of U.S. Provisional Patent Application No. 60/372,520, filed Apr. 12, 2002, the disclosures of all said applications being hereby incorporated herein by reference. The present application and the '925, '786, and '028 Applications also claim the benefit of U.S. Provisional Patent Application No. 60/449,642 filed Feb. 24, 2003.

FIELD OF THE INVENTION

This invention relates generally to artificial disc replacements (ADRs) and, more particularly, to devices that operate without softer spacer materials such as polyethylene.

BACKGROUND OF THE INVENTION

Polyethylene spacers are common in some artificial joint situations, including total knee replacements (TKRs). Polyethylene spacers are also used between metal plates in many artificial disc replacement (ADR) designs.

Complications arising from poly debris are well documented, however, including fracture of the spacer once it becomes too thin, absorptions and migration of poly particles throughout the body, and loosening of the bone metal junction as a reaction of the poly debris.

Metal-on-metal and ceramic-on-metal surfaces have much lower wear characteristics. In fact, metal-on-metal surfaces demonstrate 400 times less wear than polyethylene on metal surfaces.

While there have been attempts to limit the use of the poly in ADR designs, all existing approaches constitute call-and-socket configurations which do not inherently limit axial rotation. Instead, axial rotation is limited through the use of multiple ball-and-socket joints or an elongated ball-and-socket joint, which complicates the design.

SUMMARY OF THE INVENTION

The present invention replaces polyethylene artificial disc replacement (ADR) spacers with harder, more wear resistant materials. In the preferred embodiments, an ADR according to the invention includes opposing saddle-shaped components to facilitate more normal spinal flexion, extension, and lateral bending. Preferably, the ADR allows at least 10 degrees of movement on the flexion to extension direction and at least 5 degrees of movement in the lateral bending direction. The saddle-shaped articulating surfaces also limit axial rotation, thereby protecting the facet joints and the annulus fibrosis (AF).

According to the invention, either or both the superior and inferior components are made of a hard material such as chrome cobalt, titanium, or a ceramic including alumina, zirconia, or calcium phosphate. The articulating surfaces of the ADR are also preferably highly polished to reduce friction between the components. Metals, alloys or other materials with shape-memory characteristics may also prove beneficial.

The vertebral surfaces of the components may be treated to promote bone ingrowth. For example, the vertebral surfaces of the components may have plasma spray or beads. Alternatively, one or both components may be cemented to the vertebrae. The vertebra-facing surfaces may also include projections such as keels that fit into the vertebrae. In embodiments adapted for cementation, one of the components could be made of polyethylene or other softer material.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an anterior view of an ADR according to the invention;

FIG. 1B is a lateral view of the ADR of FIG. 1;

FIG. 1C is an oblique view of the ADR of FIG. 1;

FIG. 2A is a view of the anterior aspect of an alternative embodiment of the ADR;

FIG. 2B is a view of the lateral aspect of an alternative embodiment of the ADR shown in FIG. 2B;

FIG. 3A is a view of the anterior aspect of an alternative, less constrained, embodiment of the saddle-shaped ADR shown in a fully flexed position;

FIG. 3B is a view of the lateral aspect of the embodiment of the ADR shown in FIG. 3A;

FIG. 4A is a view of the lateral aspect of another embodiment of a saddle-shaped ADR;

FIG. 4B is a view of the anterior aspect of the embodiment of the ADR shown in FIG. 4A in a fully flexed position;

FIG. 4C is a view of the anterior aspect of an alternative embodiment;

FIG. 4D is a view of the anterior aspect of the ADR shown in FIG. 4A; and

FIG. 4E is a view of the anterior aspect of the ADR shown in FIG. 4A.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1A is an anterior view of an ADR according to the invention. FIG. 1B is a lateral view of the ADR of FIG. 1. FIG. 1C is an oblique view of the ADR of FIG. 1.

FIG. 2A is a view of the anterior aspect of an alternative embodiment of the ADR, wherein the articulating surfaces of both components have a flat area centrally from the front to the back of the ADR. FIG. 2B is a view of the lateral aspect of an alternative embodiment of the ADR drawn in FIG. 2B. The flat area of the articulating surfaces courses centrally from side of the DR to the other side. The flat area allows one component to translate slightly on the other component. Alternatively, a curved area with a large radius could replace the flat area.

FIG. 3A is a view of the anterior aspect of an alternative, less constrained, embodiment of the saddle-shaped ADR drawn in a fully flexed position. The less constrained embodiment facilitates spinal flexion, extension, and lateral bending. FIG. 3B is a view of the lateral aspect of the embodiment of the ADR drawn in FIG. 3A.

FIG. 4A is a view of the lateral aspect of another embodiment of a saddle-shaped ADR. The center of rotation for flexion and extension is not necessarily located in the center of the ADR. For example, the center of rotation is preferably located in the posterior half of the ADR. FIG. 4B is a view of the anterior aspect of the embodiment of the ADR drawn in FIG. 4A, drawn in a fully flexed position.

FIG. 4C is a view of the anterior aspect of an alternative embodiment, showing how the radius of curvature of the articulation for lateral bending may be different than the radius of curvature for articulation for flexion and extension. For example, the radius of curvature for the articulation for flexion and extension, as seen in FIG. 4A, may be smaller than the radius of curvature for the articulation for lateral bending, as seen in FIG. 4C. Articulating surfaces with smaller radii, facilitate movement. Thus, the embodiment of the ADR drawn in FIG. 4A flexes and extends more easily than the embodiment of the ADR drawn in FIG. 3A. The ADR is drawn in a fully flexed position.

FIG. 4D is a view of the anterior aspect of the ADR drawn in FIG. 4A. The ADR is drawn in a neutral position. The area of the drawing with diagonal lines represents the articulating surface of the lower ADR component. FIG. 4E is a view of the anterior aspect of the ADR drawn in FIG. 4A, also drawn in a fully extend position. 

The invention claimed is:
 1. An artificial disc replacement (ADR) configured for positioning between vertebral bodies, said artificial disc replacement comprising: a first saddle-shaped component having a first articulating surface and a first vertebral contact surface for contacting a first vertebral body, the first vertebral contact surface including at least one projection for engaging the first vertebral body, and the first articulating surface including first and second lateral edges and a toroidal region extending between the first lateral edge and the second lateral edge; and a second saddle-shaped component having a second articulating surface directly engaged with the first articulating surface and a second vertebral contact surface for contacting a second vertebral body, the second vertebral contact surface including at least one projection for engaging the second vertebral body, and the second articulating surface including third and fourth lateral edges and a toroidal region extending between the third lateral edge and the fourth lateral edge, wherein the toroidal regions of the first and second articulating surfaces, respectively, are defined by continuous curves, wherein the first articulating surface is defined by a concave arc having a radius of curvature A about a first axis, and a convex arc having a radius of curvature B about a second axis perpendicular to the first axis, and the second articulating surface is defined by a convex arc having a radius of curvature C about a third axis, and a concave arc having a radius of curvature D about a fourth axis perpendicular to the third axis, the radius of curvature A, D of at least one of the concave arcs being different than the radius of curvature B, C of at least one of the convex arcs, wherein the first and second saddle-shaped components are configured to facilitate normal spinal flexion, extension, and lateral bending, while limiting axial rotation.
 2. The artificial disc replacement of claim 1, wherein the second articulating surface is located in at least a posterior portion of the second component.
 3. The artificial disc replacement of claim 1, wherein the projections are selected from the group consisting of flanges and keels.
 4. The artificial disc replacement of claim 3, wherein the projections are keels that extend from the first and second vertebral contact surfaces of the first and second components, respectively.
 5. The artificial disc replacement of claim 1, wherein the first articulating surface includes a single substantially continuous concave surface and a single substantially continuous convex surface, and the second articulating surface includes a single substantially continuous concave surface and a single substantially continuous convex surface.
 6. The artificial disc replacement of claim 1, wherein the radius of curvature A, D of at least one of the concave arcs is greater than the radius of curvature B, C of at least one of the convex arcs.
 7. An artificial disc replacement (ADR) configured for positioning between vertebral bodies, said artificial disc replacement comprising: a first saddle-shaped component having a first articulating surface and a first vertebral contact surface for contacting a first vertebral body, the first vertebral contact surface including at least one projection for engaging the first vertebral body, and the first articulating surface including a toroidal region with a first continuous convex arc and a first continuous concave arc, each arc having a respective radius of curvature, wherein the first articulating surface is defined by first and second lateral edges, the first continuous concave arc spanning between the first and the second lateral edge; and a second saddle-shaped component having a second articulating surface directly engaged with the first articulating surface and a second vertebral contact surface for contacting a second vertebral body, the second vertebral contact surface including at least one projection for engaging the second vertebral body, and the second articulating surface including a toroidal region with a second continuous convex arc and a second continuous concave arc, each arc having a respective radius of curvature, wherein the second articulating surface is defined by third and fourth lateral edges, the second continuous convex arc spanning between the third and the fourth lateral edge, the radius of curvature of at least one of the concave arcs being different than the radius of curvature of at least one of the convex arcs, wherein at least the second articulating surface is located in at least a posterior portion of the second component, wherein the first and second saddle-shaped components are configured to facilitate normal spinal flexion, extension, and lateral bending, while limiting axial rotation.
 8. The artificial disc replacement of claim 7, wherein the projections are selected from the group consisting of flanges and keels.
 9. The artificial disc replacement of claim 8, wherein the projections are keels that extend from the first and second vertebral contact surfaces of the first and second components, respectively.
 10. The artificial disc replacement of claim 7, wherein the first concave arc has a radius of curvature A about a first axis and the first convex arc has a radius of curvature B about a second axis perpendicular to the first axis, and wherein the second convex arc has a radius of curvature C about a third axis and the second concave arc has a radius of curvature D about a fourth axis perpendicular to the third axis.
 11. The artificial disc replacement of claim 10, wherein the radius of curvature A, D of at least one of the concave arcs is greater than the radius of curvature B, C of at least one of the convex arcs. 